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Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)

 

Active pharmaceutical ingredient (API) manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate.Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements,what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm.

Active pharmaceutical ingredient (API) manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm.

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